Similar Virologic and Immunologic Efficacy With Fosamprenavir Boosted With 100 mg or 200 mg of Ritonavir in HIV-Infected Patients: Results of the LESS Trial
| Autor: | Calvin J. Cohen, Linda Yau, Anthony LaMarca, Paul Wannamaker, Benjamin Young, Mary Beth Wire, Edwin DeJesus, Mark S. Shaefer, Lisa G. Patel, Cindy Vavro |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty HIV Infections Fosamprenavir Pharmacology Gastroenterology Young Adult Internal medicine medicine Clinical endpoint Humans Hiv infected patients Pharmacology (medical) Furans Adverse effect Triglycerides Aged Sulfonamides Ritonavir Dose-Response Relationship Drug business.industry Drug Synergism HIV Protease Inhibitors Middle Aged Organophosphates Confidence interval CD4 Lymphocyte Count Discontinuation Regimen Cholesterol Infectious Diseases HIV-1 RNA Viral Female Carbamates business medicine.drug |
| Zdroj: | HIV Clinical Trials. 11:239-247 |
| ISSN: | 1945-5771 1528-4336 |
| Popis: | ritonavir (RTV) effectively boosts most protease inhibitors but is associated with significant dose-dependent adverse events (AEs). In an effort to better manage toxicities through a reduced dose of RTV, this study compared fosamprenavir (FPV) boosted with RTV 100 mg (FPV/r100) or with RTV 200 mg (FPV/r200) daily.this 24-week, open-label study enrolled patients taking a FPV/r 200-containing regimen who had HIV RNA400 copies/mL and randomized them 1:2 to continue that regimen or simplify to FPV/r100 once daily. Other medications were not altered. The primary endpoint was the percentage of patients without suspected or confirmed virologic failure (HIV RNA ≥ 400 copies/mL) through week 24 by a missing/discontinuation equals failure (M/D=F) analysis. Noninferiority criteria were demonstrated if the lower bound of the 95% confidence interval (CI) for the difference in the primary endpoint rates between groups was greater than -12.the 2 regimens met prespecified noninferiority criteria (FPV/r100, 92%; FPV/r 200, 94%; 95% CI, -9.36 to 5.12). At week 24, the percentage of patients with HIV RNA50 copies/mL by M/ D=F was 83% in the FPV/r100 group and 85% in the FPV/r 200 group. Drug-related grade 2-4 AEs were uncommon (FPV/r100, 4%; FPV/r 200, 7%). Median changes in lipids were similar in both groups, with the exception of triglycerides (FPV/r100, -21 mg/dL; FPV/r 200, -2 mg/dL).this 24-week study demonstrated that among previously suppressed patients, once-daily FPV/r100 was similar to FPV/r 200 in virologic and immunologic effects but was associated with greater decreases from baseline in triglyceride levels. |
| Databáze: | OpenAIRE |
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